Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants

Novartis

Status and phase

Completed

Phase 1

Conditions

Osteoarthritis

Knee

Treatments

Drug: LNA043

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04564053

CLNA043A11101

Details and patient eligibility

About

The objective of this study was to determine the safety, tolerability and pharmacokinetics after single ascending dose of LNA043 in Japanese participants with osteoarthritis of the knee.

Full description

This was a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study to investigate the safety, tolerability and PK of LNA043 in Japanese participants with osteoarthritis of the knee. This study consisted of 2 cohorts with a total of 12 participants.

Enrollment

12 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female Japanese participants aged 20 to 80 years at screening
A body mass index (BMI) 16.0 kg/m2 or more but less than 35.0 kg/m2 at screening
Established diagnosis of primary tibio-femoral osteoarthritis of the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months prior to screening (clinical and radiological criteria).

Exclusion criteria

Partial or complete joint replacement in the target knee. Planned knee surgery for either knee during the study.
Arthroscopy of the target knee within 6 months prior to Screening or planned during the study
Use of electrotherapy, acupuncture, and/or chiropractic treatments for osteoarthritis of the knee within 4 weeks prior to screening
Malalignment >10° in the target knee (varus/valgus)